Pharmacovigilance


At Stendhal, we are committed to maintaining the safety and efficacy of our products; therefore, all our actions are aligned with the best quality and pharmacovigilance practices and comply with local and international laws and regulations.


  • What is pharmacovigilance?
  • Purposes of Pharmacovigilance
  • What is an adverse reaction and how to detect it?
  • What should I do if I have an adverse reaction or side effect after taking medication?
  • What happens to Pharmacovigilance information?
What is pharmacovigilance?

Pharmacovigilance encompasses a set of activities that allow us to identify, evaluate, understand, and prevent adverse events (also known as side effects) that can arise after administering medication, or any other problem related to medicinal products.

At the Stendhal Pharmacovigilance Unit, we are dedicated to collecting and analyzing information on the safety and efficacy of our products, and their impact on patient health. This allows us to establish the risk-benefit balance of the product; that is, an evaluation of its safety against the side effects that may occur after its administration.

Patients and/or their caregivers should keep in mind that the above is not a "rule", since the side effects reported after using a medicinal product may vary according to each person's body. This means that not all patients experience the same side effects nor with the same intensity.

Purposes of Pharmacovigilance
  1. Report in a timely manner all adverse events (also known as side effects) experienced by our patients during treatment with any of our products.
  2. Identify in a timely manner any incident related to the use of our products.
  3. Encourage the safe, rational, and effective use of our products.
  4. Promote pharmacovigilance education.
  5. Contribute to the evaluation of the benefits, risks, and effectiveness of our products.
  6. Ensure the well-being and safety of our patients in relation to the use of our products.
  7. Improve public health and the safety of our patients in relation to the use of our products.
What is an adverse reaction and how to detect it?

An adverse reaction (also called a side effect) refers to any medically unfavorable situation that you may experience, including possible changes in the results of laboratory tests (biometrics, cultures, blood pressure, insulin, urine, etc.), which can occur after taking medication.

What should I do if I have an adverse reaction or side effect after taking medication?

If you have any side effects, you can send us a report through our official communication channels. It is also very important that you notify your treating physician.

At Stendhal, we have various forms of contact through which you can inform us of any side effects experienced during your treatment with one of our products.

Call Center :
México: 8002650001
Colombia: 18005191023
Ecuador: 1800001537
Panamá: 008002030067
República Dominicana: 18002039540
Honduras: 80027916148 Perú: 972 157 457

Speak with a pharmacovigilance specialist
(agregar link de chat) **TBD*.

E-mail:
farmacovigilancia@stendhalpharma.com

Submit your report through our website:
https://portal.phss.mx/fv_publica/servlet/com.fvpublica.capturaeventoadversopacientes2

All interactions you may have with our pharmacovigilance unit will be handled respectfully by a healthcare professional (pharmacovigilance specialist).
Los datos proporcionados serán tratados conforme a la ley de protección de datos personales en posesión de particulares. Puedes consultar nuestro aviso de privacidad dando click aquí.

Business hours: 7:00 a.m. to 5:00 p.m. (Mexico City time)
All reports received outside of working hours will be responded to first thing in the morning on the following business day.

What happens to Pharmacovigilance information?

The information provided through the Stendhal Pharmacovigilance Unit is evaluated and reported to the manufacturer; subsequently, the health authority of the corresponding country is notified in accordance with the appropriate national health regulations, always protecting the privacy of our patients and informants.
Pharmacovigilance is a practice regulated by the laws of each country where we distribute our products; therefore, compliance is mandatory for us as a pharmaceutical company, as well as for all health professionals involved in the use of medicinal products.
The identification of side effects in patients contributes to improving public health and ensuring the safety of those who use our products.
The Stendhal Pharmacovigilance Unit does not and will never disclose or publish the personal data of our patients or informants (family members, physicians, caregivers, etc.).
All information provided is strictly secured and protected, ensuring the confidentiality of our patients, healthcare professionals, and anyone else who provides us with information.



Did you have a reaction to your medication?


Your health is of utmost importance to us
Report any adverse reactions to your medication.


REPORT THE EVENT HERE

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Tel. +(52) 55 2000 66 30
Address: Camino a Santa Teresa No. 1040, Mezzanine 1, Col. Jardines en la Montaña,
Alcaldía Tlalpan, C.P. 14210, Ciudad de México, México

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